US7713237B2 - Surgical cassette for intraocular pressure control - Google Patents

Abstract

An improved surgical cassette for controlling intraocular pressure during ophthalmic surgery.

Description

FIELD OF THE INVENTION

The present invention generally pertains to microsurgical systems and more particularly to controlling intraocular pressure in ophthalmic surgery.

DESCRIPTION OF THE RELATED ART

During small incision surgery, and particularly during ophthalmic surgery, small probes are inserted into the operative site to cut, remove, or otherwise manipulate tissue. During these surgical procedures, fluid is typically infused into the eye, and the infusion fluid and tissue are aspirated from the surgical site.

Maintaining an optimum intraocular pressure during ophthalmic surgery is currently problematic. When no aspiration is occurring, the pressure in the eye becomes the pressure of the fluid being infused into the eye. This pressure is typically referred to as the “dead head pressure”. However, when aspiration is applied, the intraocular pressure drops dramatically from the dead head pressure due to all the pressure losses in the aspiration circuit associated with aspiration flow. Therefore, ophthalmic surgeons currently tolerate higher than desired dead head pressures to compensate for occasions when aspiration would otherwise lower the intraocular pressure to soft-eye conditions. Clinically, such over-pressurizing of the eye is not ideal.

Accordingly, a need continues to exist for improved apparatus for controlling intraocular pressure during ophthalmic surgery.

SUMMARY OF THE INVENTION

In one aspect, the present invention is a surgical cassette including a dual infusion chamber and first through fourth fluid lines. The dual infusion chamber has a first chamber not fluidly coupled to the second chamber. The first fluid line is fluidly coupled to the first chamber and is for providing an irrigating fluid to the first chamber. The second fluid line is fluidly coupled to the first chamber and is for providing the irrigating fluid to a surgical device. The third fluid line is fluidly coupled to the second chamber and is for providing the irrigating fluid to the second chamber. The fourth fluid line is fluidly coupled to the second chamber and is for providing the irrigating fluid to the surgical device.

In another aspect, the present invention is a surgical cassette including an infusion chamber and a fluid line. The infusion chamber has an upper surface and a lower surface. The fluid line is fluidly coupled to the infusion chamber and is for providing an irrigating fluid to the infusion chamber. The infusion chamber has an opening disposed near the lower surface for the fluid line.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, and for further objects and advantages thereof, reference is made to the following description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic diagram illustrating infusion control in an ophthalmic microsurgical system;

FIG. 2 is a schematic diagram illustrating infusion control and irrigation control in an ophthalmic microsurgical system;

FIG. 3 is a front, perspective view of a preferred surgical cassette for use in the ophthalmic microsurgical system ofFIGS. 1 and 2; and

FIG. 4 is a front, perspective, partially fragmentary view of a dual infusion chamber of the surgical cassette ofFIG. 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The preferred embodiments of the present invention and their advantages are best understood by referring toFIGS. 1-4 of the drawings, like numerals being used for like and corresponding parts of the various drawings. As shown inFIG. 1, ophthalmicmicrosurgical system10 includes apressure cuff12; aninfusion source14; adual infusion chamber16 having achamber16aand achamber16b;fluid level sensors18 and20; aflow sensor22;filters24 and26; asurgical device29; a computer ormicroprocessor28;gas manifolds30 and32; a pressurizedgas source34;proportional solenoid valves36,38, and40; “on/off”solenoid valves42,44,46,48,50,52,54;actuators56,58,60, and62; andpressure transducers64,66, and68.Dual infusion chamber16;fluid level sensors18 and20; portions ofinfusion fluid lines70,72,74,76,78, and80; and portions ofgas lines84 and86 are preferably disposed in asurgical cassette27.Infusion source14;dual infusion chamber16;flow sensor22;filters24 and26; andsurgical device29 are fluidly coupled via infusion fluid lines70-80.Infusion source14,dual infusion chamber16,gas manifolds30 and32; pressurizedgas source34; andactuators56,58,60, and62 are fluidly coupled viagas lines82,84,86,88,90,92,94, and96.Infusion source14; fluid level sensors18-20;flow sensor22;microprocessor28; proportional solenoid valves36-40; on/off solenoid valves42-54; actuators56-62; and pressure transducers64-68 are electrically coupled viainterfaces100,102,104,106,108,110,112,114,116,118,120,122,124,126,128,130, and132.

Infusion source14 is preferably a flexible infusion source. As shown best inFIGS. 3-4,dual infusion chamber16 is preferably formed on arear surface27aofsurgical cassette27.Surgical cassette27 preferably also has atop surface27band abottom surface27c.Chambers16aand16bare preferably separated by adivider16c, andchambers16aand16bare not fluidly coupled.Dual infusion chamber16 preferably also has anupper surface16dand alower surface16e. As shown best inFIGS. 1-2,chamber16bhas anopening226 disposed on or nearlower surface16eforfluid line74, andchamber16ahas anopening228 disposed on or nearlower surface16eforfluid line72. As used in the context of the preceding sentence, “near” preferably means closer tolower surface16ethan to a transverse plane passing through a midpoint betweenlower surface16eandupper surface16d, and “near” more preferably means closer tolower surface16ethan to a transverse plane passing through a point one quarter of the distance fromlower surface16eand three quarters of the distance fromupper surface16d.Fluid level sensors18 and20 may be any suitable device for measuring the level of fluid ininfusion chambers16aand16b, respectively.Fluid level sensors18 and20 are preferably capable of measuring the level of fluid ininfusion chambers16aand16bin a continuous manner.Flow sensor22 may be any suitable device for measuring the flow rate of fluid withinfluid line80.Flow sensor22 is preferably a non-invasive flow sensor.Filters24 and26 are hydrophobic micro-bacterial filters. A preferred filter is the VERSAPOR® membrane filter (0.8 micron) available from Pall Corporation of East Hills, New York.Microprocessor28 is capable of implementing feedback control, and preferably PID control.Surgical device29 may be any suitable device for providing surgical irrigating fluid to the eye but is preferably an infusion cannula, an irrigation handpiece, or and irrigation/aspiration handpiece. The portions of fluid lines70-80 disposed insurgical cassette27, and the portions of gas lines84-46 disposed insurgical cassette27, may be any suitable line, tubing, or manifold for transporting a fluid but are preferably manifolds integrally molded intosurgical cassette27.

In operation,fluid lines70,72, and74;chambers16aand16b;fluid lines76,78, and80; andsurgical device29 are all primed with a surgicalirrigating fluid140 by pressurizinginfusion source14. Surgicalirrigating fluid140 may be any surgical irrigating fluid suitable for ophthalmic use, such as, by way of example, BSS PLUS® intraocular irrigating solution available from Alcon Laboratories, Inc.

The pressurizing ofinfusion source14 is preferably performed bypressure cuff12. More specifically,microprocessor28 sends a control signal to opensolenoid valve42 viainterface106 and to closesolenoid valves44 and46 viainterfaces108 and110, respectively.Microprocessor28 also sends a control signal to openproportional solenoid valve40 viainterface104 so thatmanifold30 supplies the appropriate amount of pressurized air to actuatepressure cuff12.Pressure transducer68 senses the pressure withingas line82 and provides a corresponding signal tomicroprocessor28 viainterface126. Solenoid valves48-54 are initially open so thatmanifold32 provides pressurized air to actuate actuators56-62 to close fluid lines72-78.Microprocessor28 sends control signals to close solenoid valves48-54 via interfaces114-120. The closing of solenoid valves48-54 actuates actuators56-62 to open fluid lines72-78. After all chambers and fluid lines are primed,microprocessor28 closes actuators56-62 and thus fluid lines72-78. Alternatively, the pressuring ofinfusion source14 may be performed solely via gravity.

After priming, a user then provides a desired intraocular pressure tomicroprocessor28 via aninput134.Input134 may be any suitable input device but is preferably a touch screen display or physical knob.Chamber16bis preferably the initial active infusion chamber.Microprocessor28 sends appropriate control signals to opensolenoid valve44 and to open proportional solenoid valve36 (via interface100) to provide an appropriate level of pressurized air tochamber16b.Pressure transducer64 senses the pressure withingas line84 and provides a corresponding signal tomicroprocessor28 viainterface124.Microprocessor28 also sends an appropriate control signal to openactuator60 and thusfluid line78.Chamber16bsuppliespressurized fluid140 to the eye viafluid lines78 and80 andsurgical device29.Flow sensor22 measures the flow rate offluid140 and provides a corresponding signal tomicroprocessor28 viainterface132.Microprocessor28 calculates a predicted intraocular pressure using the signal fromflow sensor22 and empirically determined impedance information ofmicrosurgical system10.Microprocessor28 then sends an appropriate feedback control signal toproportional solenoid valve36 to maintain the predicted intraocular pressure at or near the desired intraocular pressure during all portions of the surgery.

Fluid level sensor20 continuously monitors the decrease in the level offluid140 inchamber16bduring surgery and provides a corresponding signal tomicroprocessor28 viainterface130.Microprocessor28 performs adjustments to the air pressure provided tochamber16bto accommodate for the difference in fluid head height as the level offluid140 decreases. When the level offluid140 inchamber16breaches a bottom limit level,microprocessor28 closessolenoid valve44 andactuator60 and openssolenoid valve46 andactuators58 and62.Chamber16ais now the active infusion chamber.Microprocessor28 sends an appropriate control signal toproportional solenoid valve38 viainterface102 to provide an appropriate level of pressurized air tochamber16a.Pressure transducer66 senses the pressure withingas line86 and provides a corresponding signal tomicroprocessor28 viainterface122.Chamber16asupplies pressurized fluid140 to the eye viafluid lines76 and80 andsurgical device29.Flow sensor22 measures the flow rate offluid140 and provides a corresponding signal tomicroprocessor28 viainterface132.Microprocessor28 calculates the predicted intraocular pressure as described above and the sends an appropriate feedback signal toproportional solenoid valve38 to maintain the predicted intraocular pressure at or near the desired intraocular pressure during all portions of the surgery.Microprocessor28 closesactuator58 andfluid line74 oncechamber16bis refilled withfluid140.

Fluid level sensor18 continuously monitors the decrease in the level offluid140 inchamber16aduring surgery and provides a corresponding signal tomicroprocessor28 viainterface128.Microprocessor28 performs adjustments to the air pressure provided tochamber16ato accommodate for the difference in fluid head height as the level offluid140 decreases. When the level offluid140 inchamber16areaches a bottom limit level,microprocessor28switches chamber16bto active infusion, makeschamber16ainactive, and refillschamber16awithfluid140 viafluid line72. This cycling betweenchambers16band16acontinues throughout the surgery.

Infusion source14 is preferably monitored via a fluid level sensor (not shown) capable of providing a signal tomicroprocessor28 viainterface112 whensource14 reaches a near empty limit.Chambers16aand16balso preferably each have a volume that enableinfusion source14 to be exchanged, when near empty, without interrupting the surgical procedure. More specifically,chambers16aand16bpreferably each have a volume of about 30 cc. Such volume allows about two minutes for a nearempty infusion source14 to be exchanged during conditions of maximum flow (e.g. core vitrectomy). In addition, sincefluid lines72 and74 are fluidly coupled tochambers16aand16b, respectively, at or nearlower surface16e, onceinfusion source14 is exchanged all air bubbles withinfluid lines70,72, and74 will be automatically “scrubbed out” as theinactive chamber16aor16brefills, without the need for re-priming.

In the case of failure of either ofchambers16aor16b,microprocessor28 can preferably continue surgery with only one active chamber. In the case of failure of bothchambers16aand16b,microprocessor28 can preferably continue surgery usingonly infusion source14.

FIG. 2 shows a modified ophthalmicmicrosurgical system10a.Microsurgical system10ais similar tomicrosurgical system10 except that it has an irrigation system in addition to the infusion system described above forsystem10. More specifically,system10ais identical tosystem10 except thatsystem10aalso includes anirrigation source200;fluid lines202 and206;gas lines208 and216;solenoid valves210 and218;actuators214 and222;electrical interfaces212 and220; and asurgical device224. As shown inFIG. 2,irrigation source200 is pressurized solely by gravity. The portions offluid lines202 and206 disposed insurgical cassette27, and the portions ofgas lines208 and216 disposed insurgical cassette27, may be any suitable line, tubing, or manifold for transporting a fluid but are preferably manifolds integrally molded intosurgical cassette27. As will be appreciated by one of ordinary skill in the art,microsurgical system10aallows surgical irrigatingfluid140 to be delivered tosurgical device29 via fluid line80 (infusion), and surgical irrigatingfluid140 to be delivered tosurgical device224 via fluid line206 (irrigation), independently.Microprocessor28 can calculate flow information forfluid140 withinfluid line206 by continuously monitoring the volumetric change of fluid insidechamber16b, as indicated byfluid sensor20.

From the above, it may be appreciated that the present invention provides an improved method of controlling intraocular pressure with a microsurgical system. The present invention is illustrated herein by example, and various modifications may be made by a person of ordinary skill in the art. For example, while the present invention is described above relative to controlling intraocular pressure in an ophthalmic microsurgical system, it is also applicable to controlling pressure within the operative tissue during other types of microsurgery.

It is believed that the operation and construction of the present invention will be apparent from the foregoing description. While the apparatus and methods shown or described above have been characterized as being preferred, various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined in the following claims.

Claims (4)

1. A surgical cassette, comprising:

a dual infusion chamber for receiving an irrigating fluid from a source external to said cassette, said dual infusion chamber disposed within an interior of said surgical cassette, said dual infusion chamber having a first chamber and a second chamber, each of said first chamber and said second chamber having a volume sufficient to hold an amount of irrigating fluid to enable said source of irrigating fluid to be exchanged without interrupting a surgical procedure, said first chamber not fluidly coupled to said second chamber;

a first fluid line fluidly coupled to said first chamber for providing said irrigating fluid to said first chamber;

a second fluid line fluidly coupled to said first chamber for providing said irrigating fluid to a surgical device;

a third fluid line fluidly coupled to said second chamber for providing said irrigating fluid to said second chamber; and

a fourth fluid line fluidly coupled to said second chamber for providing said irrigating fluid to said surgical device.

2. The surgical cassette ofclaim 1 wherein said first chamber and said second chamber are separated by a divider.

3. The surgical cassette ofclaim 1 wherein said volume is sufficient for about two minutes of said surgical procedure during a condition of maximum flow.

4. The surgical cassette ofclaim 1 wherein said volume is about 30 cc.

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